BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.
This study has been completed.
Sponsor:
Community Research Initiative of New England
Collaborators:
Bristol-Myers Squibb
Merck
Information provided by (Responsible Party):
Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00931801
First received: June 30, 2009
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: atazanavir/raltegravir Drug: atazanavir/tenofovir/emtricitabine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine |
Resource links provided by NLM:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Atazanavir
Tenofovir Disoproxil Fumarate
Atazanavir sulfate
Raltegravir
Truvada
Raltegravir potassium
U.S. FDA Resources
Further study details as provided by Community Research Initiative of New England:
Primary Outcome Measures:
- Maintenance of Virologic Suppression [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.
Secondary Outcome Measures:
- The Difference in CD4 From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]Change in mean CD4 from Baseline to Week 48.
- The Change in Adherence to Study Treatment Arm From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.
- Change in Quality of Life From Baseline to 48 Weeks of Study Treatment [ Time Frame: baseline and 48 weeks ] [ Designated as safety issue: No ]Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.
| Enrollment: | 43 |
| Study Start Date: | December 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intervention Arm No.1 |
Drug: atazanavir/raltegravir
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
|
| Experimental: Intervention Arm No.2 |
Drug: atazanavir/raltegravir
Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
|
Active Comparator: Control Arm
Continue baseline regimen
|
Drug: atazanavir/tenofovir/emtricitabine
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Other Name: Truvada
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-1 infection
- Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
- No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
- Undetectable HIV RNA at screening AND no HIV RNA>200 copies during the 180 day period prior to screening
- CD4 count>200
- No evidence of resistance to any of the drugs in any of the 3 arms, if prior resistance tests are available
- Subjects who, in the opinion of their treating physicians, would be candidates to switch antiretroviral medications
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug
- Ability and willingness to provide written informed consent and comply with protocol requirements
Exclusion Criteria:
- Prior exposure to raltegravir or elvitegravir
- Women who are pregnant, breast-feeding, or with a positive pregnancy test
- Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
- Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
- Life expectancy less than 6 months
- Presence of any currently active AIDS defining conditions with the exception of stable cutaneous Kaposi's sarcoma
- Treatment with proton-pump inhibitor or H2-receptor antagonist
- ECG demonstrating atrioventricular block, prolonged QRS interval greater than 12 ms, or known complete bundle branch block
- Acute or chronic hepatitis B infection as evidenced by presence of hepatitis B surface antigen and absence of hepatitis B surface antibody
- Clinical or laboratory evidence of significantly decreased hepatic function of decompensation irrespective of liver enzyme levels
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931801
Locations
| United States, Arizona | |
| Spectrum Medical Group | |
| Phoenix, Arizona, United States, 85012 | |
| United States, California | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 90028 | |
| United States, Colorado | |
| Denver Public Health | |
| Denver, Colorado, United States, 80204 | |
| United States, District of Columbia | |
| Whitman-Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32803 | |
| Treasure Coast Infectious Disease Consultants | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Kansas | |
| Christi Research | |
| Wichita, Kansas, United States, 67214 | |
| United States, Massachusetts | |
| Community Research Initiative of New England - Boston | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Texas | |
| David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group | |
| Dallas, Texas, United States, 75804 | |
Sponsors and Collaborators
Community Research Initiative of New England
Bristol-Myers Squibb
Merck
Investigators
| Principal Investigator: | Calvin J Cohen, MD, MSc | Community Research Initiative |
More Information
No publications provided
| Responsible Party: | Cal Cohen, Director of Research, Community Research Initiative of New England |
| ClinicalTrials.gov Identifier: | NCT00931801 History of Changes |
| Other Study ID Numbers: | 09-102 |
| Study First Received: | June 30, 2009 |
| Results First Received: | February 5, 2013 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Community Research Initiative of New England:
|
AIDS HIV Atazanavir |
Raltegravir Tenofovir protease inhibitors |
Additional relevant MeSH terms:
|
Tenofovir Tenofovir disoproxil Atazanavir Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013